Process Validation

An Introduction to Process Validation – Part 2

In the second part of our program on process validation, you will learn in more detail, the different steps that constitute process validation. We will look at the qualification of equipment and the steps that need to be performed during a validation study. This will also include a discussion of the validation protocol, how it should be written and approved. Finally, we discuss the differences between the traditional and the new life cycle approach.

CEU Credits: 0.1
Course Code: ELM-402
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 09/07/2021

Curriculum for this course

Overview
Course structure
Learning objectives
Who should take this course?
Course modules
Overview
Qualification of equipment
Design qualification
User requirement specification
Functional requirement specification
Operational requirements
Vendor qualification
Installation qualification
Installation qualification protocol
Operational qualification
Operational qualification protocol
Performance qualification
Review activity
Overview
What is process validation?
The stages of process validation
Stage 1: Process design
Stage 2: Process validation
Stage 3: Continuous process validation
Review activity
Overview
Traditional Approach
Modern Approach to Process Validation
Traditional vs New Life Cycle Approach to Validation
Quality Risk Management
Quality by Design
Quality by Design (Continued)

Conclusion

Final Exam

Minor Update: Fixed quiz functionality issue
V1.1

Author

Ginny Ojingwa

Sr. QA Lead III Genzyme

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